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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Demystifying FDA’s 505(b)(2) Drug Registration Process

Posted 01 October 2009 | By

The US Food and Drug Administration's (FDA) legal/regulatory framework offers three pathways to approval of New Drug Applications (NDAs): 505(b)(1), 505(b)(2) and 505(j). This article provides an overview of the 505(b)(2) process in comparison to the other registration processes. In 2008, more than half of the new drugs approved in the US utilized the 505(b)(2) registration pathway. Of the 28 drug approvals in 2008 under this pathway, 50% were products with new formulations and the remainder were principally products with new molecular entities, changed active ingredients and new drug combinations. This reflects an increase from 2006 and 2007, for which the percentages were 20% and 43%, respectively.1